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(As on Jul 12, 2018, 13:08)

Lupin gets USFDA nod for generic Nitrofurantoin Capsules

Pharma major Lupin said that it has received final approval for its Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen Malta Operations Ltd.'s Macrodantin® Capsules, 50 mg and 100 mg.

Lupin's Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg is the generic version of Alvogen Malta Operations Ltd.'s Macrodantin® Capsules, 50 mg and 100 mg, the company said in a filing to the Bombay Stock Exchange.

It is specifically indicated for the treatment of urinary tract infections (UTI) when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg had annual sales of approximately USD 27 million in the US (IQVIA MAT April 2018).

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